Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement
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|ClinicalTrials.gov Identifier: NCT00548392|
Recruitment Status : Completed
First Posted : October 24, 2007
Last Update Posted : December 31, 2008
|Condition or disease|
Many breast cancers and other breast lesions are discovered as a palpable abnormality by patients or their providers during a breast exam. Diagnostic imaging and biopsy of these lesions may reveal high-risk or malignant findings. These palpable lesions can be removed in the operating room by the surgeon using touch as guidance. However, there are many lesions discovered by screening examinations that surgeons cannot palpate. When this occurs, a radiologist will percutaneously place a wire or wires at the site of the breast lesion using sonographic or mammographic guidance. The surgeon then uses the wires as a guide for complete and successful resection of the lesion.
New marker devices have been developed that are sonographically visible. They consist of the standard mammographically visible metallic clip surrounded by a sonographically visible collagen plug. It is hypothesized that radiologists and surgeons can effectively localize the clip with intra-operative ultrasound and then resect the lesion. If so, the pre-operative wire localization procedure could be eliminated. This could improve the patient experience while saving time and money by reducing the number of invasive procedures from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Sonographic Visibility of Breast Biopsy Marker Clips Up to 4 Weeks After Placement|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
- Visibility of marker clip after placement in suspicious breast lesions. [ Time Frame: Within 4 weeks of placement ]
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548392
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Peter R Eby, MD||University of Washington|